A company that Gatundu South MP Moses Kuria said sold him a warm mat that burnt his feet has defended its product, even as a lobby group piled pressure to regulate heat therapy.
The Pharmaceutical Society of Kenya (PSK) stepped up the campaign for enactment of the Kenya Food and Drug Authority (KFDA) Bill to reform the regulation of health products and technologies.
Mr Kuria’s hospitalisation after botched heat therapy has evoked conflicting opinions online and thrown the spotlight on unregulated medical products.
For a fortnight now, Karen Hospital has teemed with politicians visiting their colleague, who is bedridden after his treatment went awry.
The towering parliamentarian told Citizen TV that he felt shortchanged after a gadget he acquired from a friend made his feet ‘explode’. He was later confirmed to have had third degree burns and had to undergo surgery.
In his words, “I was trying to cure a problem by introducing a killer solution.”
Mr Kuria now says that he has sought a ministerial statement in Parliament from Cabinet secretaries for Trade and Industry, and for Health to understand the extent of the proliferation of unregulated products in Kenya.
“All medical appliances and devices are supposed to be applied only from a hospital or approved health facilities. It is something that we sometimes think that the government is too harsh (about), but see the effect. We need to have a total clampdown,” he said in the TV interview.
“I thought I would use my case to save other people that are using products outside (hospitals) that it is extremely dangerous.”
The politician also alleged that the gadget, which the Nation has learnt is called a warm mat, is not approved by the Kenya Bureau of Standards.
The Nation reached out to Ceragem, the company that Mr Kuria said his friend acquired the mat from.
While the legislator said on TV that the warm mat cost him Sh250,000, Martin Mulwa, Ceragem’s communication’s director, told the Nation that Mr Kuria exaggerated the price.
“Moses Kuria did not buy the warm mat from us. He bought it from his friend. The warm mat retails at Sh55,000 and not the Sh250,000 that he said on live TV,” Mr Mulwa said.
Ceragem has sold its products in Kenya for the past 13 years, he said, and to the best of their knowledge, this is the first adverse event they have heard about.
But the company insists they are not sure whether the product Mr Kuria used is theirs, as he did not personally acquire it from them.
Ceragem yesterday shared with the Nation three certificates of conformity, with the Kenya Bureau of Standards logo on them to show that the product is approved for use in Kenya.
Two electromagnetic test reports from Korea, where the product is manufactured, also show that Ceragem passed its test.
Mr Mulwa told the Nation that people with pre-existing conditions are not supposed to use some of Ceragem’s products, such as the warm mat.
“People with diabetic neuropathy (nerve damage that occurs in people with diabetes), those with heart conditions or any nerve-related problems are advised against using the mats. In fact, there are people who are completely prohibited from using it, such as pregnant women and those with a hole in the heart,” he explained.
“I think that is why it reacted with the MP.”
The warm mat, Mr Mulwa said, is not a medical product and the company that sells it is not a hospital. He also said that it is not an electric blanket as most netizens have described it.
Though it is not a medical product, Ceragem Kenya, on its website, contains testimonials from customers who describe it as one with “life-changing results of revitalizing the body and rejuvenating the health”.
The gazetted Kenya Food and Drug Authority (KFDA) Bill defines a medical device as any “material, instrument, apparatus or contrivance (gadget) whether radiation omitting or not, including parts and accessories thereof, manufactured, sold or represented for use in the diagnosis, treatment, monitoring, mitigation or prevention of any disease disorder or any abnormal physical state or disability of the symptoms thereof, in humans or animals but does not include medicines”.
While heat therapy is gaining popularity, especially in Kenya’s urban areas, little is known about its effect on people’s bodies, considering most of the equipment used applies infrared rays, which use radiation.
The Pharmaceutical Society of Kenya (PSK), in a press statement, empathised with Mr Kuria for using what they called an “unregulated product” but asked Parliament to consider the group’s views on the KFDA Bill.
PSK chief executive Daniella Munene insisted that the KFDA Bill, which seeks to overhaul the regulation of health products and technologies, needs to be amended.
On Mr Kuria’s botched heat therapy, she said: “Those are borderline products, which means that they are not clear whether they are for medical use or for just consumer use.”
“In general, all medical devices, medicines and health technologies should come under the regulation of one body and this body should be called the medicine and health products authority,” she added.
Dr Munene said Kenya needs a bill that is dedicated to medical products, separate from food.
“We gave Parliament our views and our memorandum but they have not adopted it. We ask that the body should not be regulating ordinary food but medical products. If it is food, let it be the ones used for treatment, like injectable vitamins, multivitamins or total parenteral nutrition,” she said.
“We also want to rename the bill to the Medicine and Health Products Bill.”